Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Via Capsules for Intestinal Multidrug-resistant Bacteria Decolonization
Recruiting
Phase 1
Phase 2
Interventional Study
Colonization, Asymptomatic
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 48 (estimated)
- Sponsor
- University of Rijeka · Other
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About This Trial
The goal of this clinical trial is to learn if oral capsules containing lyophilized stool from healthy donors (fecal microbiota transplantation or FMT) can safely and effectively decolonize multidrug-resistant organisms (MDROs) from the intestines in adults. The main questions it aims to answer are:
1. Does FMT via oral capsules reduce or eliminate intestinal MDRO colonization?
2. What side effec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* ≥ 18 years,
* stool sample or rectal swab positive for MDRO (CRE, ESBL-E, VRE) within a week of randomization,
* capable of swallowing oral capsules,
* willing to give informed consent
Exclusion Criteria:
* antibiotic treatment on the day of inclusion,
* pregnant or breastfe…
Contacts